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WellKnit Ankle Brace
EUDAMEDClass I (EU MDR)
Ref 624001(XL/UNI/Black)Model AFO Splint 620001 AFO Leaf Spring 620002 Night Splint:620003 Soft Night Splint:620004 Dorsal Night Splint:620016Ref 624001(S/UNI/Black)Ref 624001(L/UNI/Black)
Identity
- Trade Name
- WellKnit Ankle Brace EUDAMED
- Device Name
- Ankle Brace, Ankle Foot Orthosis, Night Splint (Ankle/foot orthosis) EUDAMED
- Model / Reference
- AFO Splint 620001 AFO Leaf Spring 620002 Night Splint:620003 Soft Night Splint:620004 Dorsal Night Splint:620016 EUDAMED624001(XL/UNI/Black) EUDAMED624001(S/UNI/Black) EUDAMED624001(L/UNI/Black) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719964461227 EUDAMED04719964461210 EUDAMED04719964461197 EUDAMED
- Basic UDI-DI
- 47199644662WL EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Ankle/foot orthosis
WellKnit Ankle Brace by Orthotech Rehabilitation Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 47199644662WL | Class I | Active |
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Manufacturer
- Manufacturer
- Orthotech Rehabilitation Co., Ltd.
- EUDAMED SRN
- CN-MF-000051924
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 5aed01d2-d250-401e-9648-74a3f778aef3 61 fields · synced Oct 6, 2026
- EUDAMED 33114e03-dd0c-485b-999a-42ab2233ed27 61 fields · synced May 18, 2026
- EUDAMED 39519feb-350d-4b7a-9742-9b503baf8e03 61 fields · synced May 19, 2026